Reported Dec 6, 2023 · Ongoing
FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- FloTrac Sensor with Vamp System
- REFMHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring
- Lot codes and dates
- MHD6AZ
UDI:00690103194722Lot #: 64818047 64858313 64891437 64953982
- MHD6AZ5UDI: 00690103194746, Lot #:
6478241964882668649120546491824664933574649880436500722365007224
- MHD6C502
UDI: 00690103194760Lot #: 64951410
- MHD6AZ
- Amount recalled
- 11,072 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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